RECRUITING

Dysport ® as an Adjunctive Treatment to Bracing in the Management of Adolescent Idiopathic Scoliosis

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Conditions

Adolescent Idiopathic ScoliosisAIS

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study evaluates the combined effect of botulinum toxin A (administered as Dysport® (Ipsen Pharmaceuticals)) and bracing in children with adolescent idiopathic scoliosis. Two thirds of patients will be treated with Dysport® and bracing, while the remaining patients will be treated with placebo and bracing.

Official Title

Dysport ® (abobotulinumtoxinA) as an Adjunctive Treatment to Bracing in the Management of Adolescent Idiopathic Scoliosis

Quick Facts

Study Start:2020-09-03
Study Completion:2026-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03935295

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:10 Years to 16 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Clinically determined idiopathic nature of scoliosis
  2. * Age 10-16 years
  3. * Risser stage 0,1,or 2
  4. * major curve of 20°-40°
  5. * curve apex caudal to T7 vertebra
  6. * ability to adhere to bracing protocol
  7. * Botulinum toxin naïve or previously treated greater than 6 months prior to study entry
  1. * Diagnosis of congenital scoliosis, neuromuscular scoliosis, or other "reason" for scoliosis - Previous surgery at any segment of the spine
  2. * Current need for surgery at any level of the spine
  3. * Treatment with any drug known to interfere with neuromuscular function
  4. * Any other medical condition, laboratory or diagnostic procedure finding that might preclude administration of BTX
  5. * Ongoing infection at the injection sites
  6. * Diagnosis as either resistant or sensitive to botulinum toxin treatment of any type or to any components of the BTX formulation
  7. * Cow milk protein allergy

Contacts and Locations

Study Contact

Gabrielle Reichard, MA
CONTACT
4105023626
greicha1@jhmi.edu
Varun Puvanesarajah, MD
CONTACT
9193605646
vpuvane1@jhmi.edu

Principal Investigator

Paul Sponseller, MD, MBA
PRINCIPAL_INVESTIGATOR
Johns Hopkins Hospital Department of Orthopaedic Surgery
Varun Puvanesarajah, MD
PRINCIPAL_INVESTIGATOR
Johns Hopkins Hospital Department of Orthopaedic Surgery

Study Locations (Sites)

Johns Hopkins University
Baltimore, Maryland, 21287
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Paul Sponseller, MD, MBA, PRINCIPAL_INVESTIGATOR, Johns Hopkins Hospital Department of Orthopaedic Surgery
  • Varun Puvanesarajah, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins Hospital Department of Orthopaedic Surgery

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-09-03
Study Completion Date2026-03-31

Study Record Updates

Study Start Date2020-09-03
Study Completion Date2026-03-31

Terms related to this study

Keywords Provided by Researchers

  • AIS
  • adolescent idiopathic scoliosis

Additional Relevant MeSH Terms

  • Adolescent Idiopathic Scoliosis